Title 21
664 sections in this title — page 3 of 7.
§ 342
Adulterated food
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 343
Misbranded food
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 343–1
National uniform nutrition labeling
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 343–2
Dietary supplement labeling exemptions
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 343–3
Disclosure
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 344
Emergency permit control
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 345
Regulations making exemptions
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 346
Tolerances for poisonous or deleterious substances in food; regulations
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 346a
Tolerances and exemptions for pesticide chemical residues
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 346b
Authorization of appropriations
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 347
Intrastate sales of colored oleomargarine
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 347a
Congressional declaration of policy regarding oleomargarine sales
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 347b
Contravention of State laws
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 348
Food additives
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 349
Bottled drinking water standards; publication in Federal Register
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 350
Vitamins and minerals
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 350a
Infant formulas
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 350a–1
Protecting infants and improving formula supply
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 350b
New dietary ingredients
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 350c
Maintenance and inspection of records
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 350d
Registration of food facilities
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 350e
Sanitary transportation practices
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 350f
Reportable food registry
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 350g
Hazard analysis and risk-based preventive controls
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 350h
Standards for produce safety
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 350i
Protection against intentional adulteration
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 350j
Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 350k
Laboratory accreditation for analyses of foods
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 350l
Mandatory recall authority
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 350l–1
Annual report to Congress
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 350m
Requirements for critical food
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD
§ 351
Adulterated drugs and devices
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 352
Misbranded drugs and devices
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 353
Exemptions and consideration for certain drugs, devices, and biological products
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 353a
Pharmacy compounding
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 353a–1
Enhanced communication
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 353b
Outsourcing facilities
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 353c
Prereview of television advertisements
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 353d
Process to update labeling for certain generic drugs
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 354
Veterinary feed directive drugs
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 355
New drugs
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 355a
Pediatric studies of drugs
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 355b
Adverse-event reporting
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 355c
Research into pediatric uses for drugs and biological products
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 355c–1
Report
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 355d
Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 355e
Pharmaceutical security
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 355f
Extension of exclusivity period for new qualified infectious disease products
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 355g
Utilizing real world evidence
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 355h
Regulation of certain nonprescription drugs that are marketed without an approved drug application
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 355–1
Risk evaluation and mitigation strategies
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 355–2
Actions for delays of generic drugs and biosimilar biological products
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 356
Expedited approval of drugs for serious or life-threatening diseases or conditions
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 356a
Manufacturing changes
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 356b
Reports of postmarketing studies
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 356c
Discontinuance or interruption in the production of life-saving drugs
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 356c–1
Annual reporting on drug shortages
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 356d
Coordination; task force and strategic plan
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 356e
Drug shortage list
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 356f
Hospital repackaging of drugs in shortage
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 356g
Standards for regenerative medicine and regenerative advanced therapies
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 356h
Competitive generic therapies
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 356i
Prompt reports of marketing status
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 356j
Discontinuance or interruption in the production of medical devices
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 356k
Platform technologies
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 356l
Advanced manufacturing technologies designation program
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 356–1
Accelerated approval of priority countermeasures
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 356–2
Accelerated approval Council
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 357
Qualification of drug development tools
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 358
Authority to designate official names
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 359
Nonapplicability of subchapter to cosmetics
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360
Registration of producers of drugs or devices
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360a
Clinical trial guidance for antibiotic drugs
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360aa
Recommendations for investigations of drugs for rare diseases or conditions
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part B— Drugs for Rare Diseases or Conditions
§ 360a–1
Clinical trials
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360a–2
Susceptibility test interpretive criteria for microorganisms
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360b
New animal drugs
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices
§ 360bb
Designation of drugs for rare diseases or conditions
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part B— Drugs for Rare Diseases or Conditions
§ 360bbb
Expanded access to unapproved therapies and diagnostics
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–0
Expanded access policy required for investigational drugs
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–0a
Investigational drugs for use by eligible patients
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–1
Dispute resolution
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–2
Classification of products
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–3
Authorization for medical products for use in emergencies
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–3a
Emergency use of medical products
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–3b
Products held for emergency use
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–3c
Expedited development and review of medical products for emergency uses
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–4
Countermeasure development, review, and technical assistance
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–4a
Priority review to encourage treatments for agents that present national security threats
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–4b
Medical countermeasure master files
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–5
Critical Path Public-Private Partnerships
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–5a
Emerging technology program
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–6
Risk communication
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–7
Notification
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–8
Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–8a
Optimizing global clinical trials
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–8b
Use of clinical investigation data from outside the United States
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–8c
Patient participation in medical product discussion
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360bbb–8d
Notification, nondistribution, and recall of controlled substances
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part E— General Provisions Relating to Drugs and Devices
§ 360b–1
Priority zoonotic animal drugs
Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices